The procedure to place a severely ill patient on a breathing machine, known as intubation, can be high-risk.
One in four severely ill patients undergoing intubation in an emergency department or intensive care unit experiences serious problems with blood pressure or oxygen levels during this procedure.
Some of these risks may be related to the medication used during the procedure to make the patient sleepy (a sedative). The two medications doctors give most often in this situation are ketamine and etomidate. Both are approved by the U.S. Food and Drug Administration (FDA), and have been in use for decades, but it is not known whether one drug is better for patients, overall, or among patients with specific medical problems.
Starting in March 2024, Atrium Health Wake Forest Baptist providers, in collaboration with Vanderbilt University Medical Center and other medical centers across the country, will initiate the “Randomized Trial of Sedative Choice for Intubation” (RSI) study to determine whether ketamine or etomidate is better for preventing low blood pressure, low oxygen levels, serious heart problems, or even death for severely ill patients undergoing intubation. Approximately 2,400 patients will be enrolled in this study across the country.
During the study, when providers are caring for a severely ill patient in the Atrium Health Wake Forest Baptist emergency department or intensive care unit who needs to be placed on a breathing machine, and they believe that ketamine and etomidate would be equally effective for that patient, the choice between the two will be made by the RSI study.
“Determining which of these two commonly used medications is best could improve care for tens of thousands of the sickest patients every year,” said Dr. Kevin Gibbs who is leading the study for the Atrium Health Wake Forest Baptist site and is an associate professor of pulmonary and critical care medicine at Wake Forest University School of Medicine.
Placing seriously ill patients on a breathing machine is an emergency procedure. Most patients requiring intubation in the emergency department or intensive care unit are unconscious or in distress. There is often no time for doctors to discuss the risks and benefits of the procedure with the patient. Physicians typically must go ahead with life-saving care without the patient’s consent. For these same reasons, doctors may not be able to get a patient’s consent to take part in the RSI study.
Important research to find the best care for life-threatening conditions, like the RSI study, is therefore conducted through a process called “Exception from Informed Consent” (EFIC), in which the study is overseen by the FDA and an independent ethics committee. Researchers meet with each patient or family member after the procedure has been completed to discuss the study.
In addition to Gibbs, the Wake Forest University School of Medicine research team includes Dr. Jessica Palakshappa, associate professor of pulmonary, critical care, allergy and immunology and Dr. John Gaillard, associate professor of anesthesiology.
The study is funded by the Patient-Centered Outcomes Research Institute (PCORI).
More information about the study can be found at https://www.pragmaticcriticalcare.org/current-trials/rsi-patient-information/.